Note that subcutaneous golimumab is currently approved for treating adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and the current data on the intravenous formulation in active ankylosing spondylitis has now been submitted to the FDA.

MADRID -- Intravenous golimumab (Simponi) was effective in treating patients with active ankylosing spondylitis, meeting all the endpoints of a phase III trial known as GO-ALIVE, a researcher reported here.

At week 16, a 20% improvement on the response criteria of the Assessment in Ankylosing Spondylitis (ASAS) International Working Group criteria was seen in 73.3% of patients randomized to golimumab, 2 mg/kg every 8 weeks compared with 26.2% of those given placebo (P<0.001), according to Atul Deodhar, MD, of Oregon Health & Science University in Portland. The difference was "quite dramatic," he told MedPage Today.

And for a 40% ASAS improvement, "which is what we really like to see in our clinical practice -- we want people to have at least a 40% response," the response rates were 47.6% versus 8.7% at week 16, Deodhar said during a poster presentation at the annual European Congress of Rheumatology.

Subcutaneous golimumab, a tumor necrosis factor (TNF) inhibitor, is currently approved for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, given as 50 mg once each month. The intravenous formulation, approved for rheumatoid arthritis, has now been evaluated in the GO-ALIVE program and submitted to the FDA.

The study included 208 patients who had a diagnosis of definite ankylosing spondylitis, with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 4 or greater, total back pain visual analog scale of at least 4, and C-reactive protein (CRP) of 0.3 mg/dL or higher.

The regimen included a loading dose in which intravenous golimumab was given as 2 mg/kg at baseline and week 4, and then every 8 weeks through week 16, at which time all patients began receiving the active treatment. The primary endpoint was ASAS20 at week 16.

More than three-quarters of the patients were men, and mean age was 39. Mean duration of disease was 5.5 years, 6% had complete ankylosis of the spine, and 90% were HLA-B27 positive. A total of 14.4% had previously been treated with an anti-TNF agent.

As early as week 2, the ASAS20 response rate was significantly higher in the golimumab group (37.1% versus 19.4%, P=0.05), and at all time points through week 16 remained significantly different from the placebo group (P=0.001). After those in the placebo group switched to the active treatment at week 16, their ASAS20 response rates improved and were maintained through week 28.

Mean changes in BASFI from baseline were -2.39 in the golimumab group at week 16 compared with -0.47 in the placebo group (P<0.001), while changes on BASMI were -0.38 versus -0.10 (P=0.001).

At week 16, a significantly greater proportion of patients in the golimumab group had achieved ASAS partial remission (16.2% versus 3.9%, P=0.003) and inactive disease, with a score below 1.3 on the ASDAI (27.6 versus 2.9, P<0.001).

"So these people started with very active disease, ASDAIs of more than 4, and at the end of just 16 weeks, nearly 30% of patients had inactive disease," he said.

Safety was similar to what has been seen with other anti-TNF therapies, including subcutaneous golimumab, he noted. During the 16 weeks, 32.4% of patients receiving golimumab had one or more adverse event, as did 23.3% of those given placebo. A total of 11.4% of patients in the active treatment group had one or more infections, as did 7.8% of those in the placebo group.

There was only serious infection, which was a case of pneumonia in a patient in the golimumab group. There were no opportunistic infections, malignancies, or deaths.

Infusion reactions, which occurred in three patients, were very minor, with no anaphylaxis, Deodhar said. During the extended follow-up through week 28, there were no further infusion reactions.

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